510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K912004Substantially Equivalent

Shepard Cryopress/camp Multi-Temp Sport Pumps

Shepherd Medical Products, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912004 is the FDA 510(k) clearance record for SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS, a class II device, cleared for Shepherd Medical Products, Inc. on under FDA product code IRP (Massager, Powered Inflatable Tube). FDA records list one 510(k) clearance for Shepherd Medical Products, Inc. As of , FDA records show no recalls naming K912004.

Clearance record

Decision date
Received
(80 days to decision)
Product code
IRP Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Applicant
Shepherd Medical Products, Inc. C/O Hogan & Hartson, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code IRP

Trailing 12 months
13 clearances under product code IRP in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code IRP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20263
May 20262
June 20261
July 20262
August 20261
September 20260
October 20262